NCT06627413

Brief Summary

Study ITI-007-037 is a Phase 1b, open-label study to evaluate the safety, tolerability, and PK of lumateperone long-acting injectable (LAI) formulations after a single intramuscular injection in patients with stale schizophrenia or schizoaffective disorder.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Aug 2024

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 23, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 2, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 4, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2025

Completed
Last Updated

March 12, 2026

Status Verified

March 1, 2026

Enrollment Period

1.2 years

First QC Date

October 2, 2024

Last Update Submit

March 11, 2026

Conditions

Schizophrenia or Schizoaffective

Outcome Measures

Primary Outcomes (6)

  • Pharmacokinetics: Cmax,oral

    Maximum plasma concentration of lumateperone

    Day 5

  • Pharmacokinetics: Cmax,IM

    Maximum plasma concentration of lumateperone

    Day 11-60

  • Pharmacokinetics: Tmax,oral

    Time of maximum concentration of lumateperone in plasma

    Day 5

  • Pharmacokinetics: Tmax,IM

    Time of maximum concentration of lumateperone in plasma

    Day 11-60

  • Pharmacokinetics: AUC0-t,oral

    Area under the plasma concentration time curve from time zero to the last measurable of concentration of lumateperone

    Day 5

  • Pharmacokinetics: AUC0-t,IM

    Area under the plasma concentration time curve from time zero to the last measurable of concentration of lumateperone

    Day 11-60

Secondary Outcomes (8)

  • Percentage of subjects with treatment-emergent adverse events

    up to 30 days after the last protocol-defined study visit

  • Change from baseline in systolic and diastolic blood pressure

    Days 25 and 60

  • Change from baseline in ECG QTcF interval

    Days 25 and 60

  • Change from baseline in hemoglobin

    Days 25 and 60

  • Change from baseline in white blood cell count

    Days 25 and 60

  • +3 more secondary outcomes

Study Arms (9)

Cohort 1

EXPERIMENTAL

Lumateperone 42 mg once daily for 5 days following by a single IM dose of lumateperone 100 mg LAI formulation X500-E2 after a 5-day washout

Drug: Lumateperone CapsuleDrug: Lumateperone LAI

Cohort 2

EXPERIMENTAL

Lumateperone 42 mg once daily for 5 days following by a single IM dose of lumateperone 100 mg LAI formulation X500-E3 after a 5-day washout

Drug: Lumateperone CapsuleDrug: Lumateperone LAI

Cohort 3

EXPERIMENTAL

Lumateperone 42 mg once daily for 5 days following by a single IM dose of lumateperone 100 mg LAI formulation X500-X2 after a 5-day washout

Drug: Lumateperone CapsuleDrug: Lumateperone LAI

Cohort 4

EXPERIMENTAL

Lumateperone 42 mg once daily for 5 days following by a single IM dose of lumateperone 100 mg LAI formulation X500-X5 after a 5-day washout

Drug: Lumateperone CapsuleDrug: Lumateperone LAI

Cohort 5

EXPERIMENTAL

Lumateperone 42 mg once daily for 5 days following by a single IM dose (\> 100 mg) of lumateperone LAI formulation (chosen from Part A) after a 5-day washout

Drug: Lumateperone CapsuleDrug: Lumateperone LAI

Cohort 6

EXPERIMENTAL

Lumateperone 42 mg once daily for 5 days following by a single IM dose (\> 100 mg) of lumateperone LAI formulation (chosen from Part A) after a 5-day washout

Drug: Lumateperone CapsuleDrug: Lumateperone LAI

Cohort 7

EXPERIMENTAL

Lumateperone 42 mg once daily for 5 days following by a single IM dose (\> 100 mg) of lumateperone LAI formulation (chosen from Part A) after a 5-day washout

Drug: Lumateperone CapsuleDrug: Lumateperone LAI

Cohort 8

EXPERIMENTAL

Lumateperone 42 mg once daily for 5 days following by a single IM dose (\> dose in Part B) of lumateperone LAI formulation (chosen from Part B) after a 5-day washout

Drug: Lumateperone CapsuleDrug: Lumateperone LAI

Cohort 9

EXPERIMENTAL

Lumateperone 42 mg once daily for 5 days following by a single IM dose (\> dose in Part B) of lumateperone LAI formulation (chosen from Part B) after a 5-day washout

Drug: Lumateperone CapsuleDrug: Lumateperone LAI

Interventions

Lumateperone CapsuleDRUG

Lumateperone 42 mg capsule, oral administration

Cohort 1Cohort 2Cohort 3Cohort 4Cohort 5Cohort 6Cohort 7Cohort 8Cohort 9
Lumateperone LAIDRUG

Lumateperone LAI X500-E2 IM injection

Cohort 1

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Male or female patients between 18 and 55 years of age, inclusive;
  • Clinical diagnosis of schizophrenia or schizoaffective disorder according to Diagnostic and Statistical Manual of Mental Disorders (DSM-5);
  • Clinically stable and free from acute exacerbation of psychosis for at least 3 months prior to Screening;
  • Clinical Global Impression - Severity (CGI-S) score ≤ 3 at Screening and prior to dosing on Day 1;
  • Body mass index (BMI) between 18.0 and 38.0 kg/m2, inclusive at Screening, and a minimum body weight of 50 kg at Screening.

You may not qualify if:

  • History of psychiatric condition other than schizophrenia that, in the Investigator's opinion, may be detrimental to participation in the study;
  • Any suicidal ideation or wish to be dead within the past 6 months of Screening, any suicide attempt within the past 2 years prior to Screening, or any current concern for the patient's safety based on the Columbia-Suicide Severity Rating Scale (C-SSRS) (excluding self-injurious, non-suicidal behavior), and/or Investigator assessment that the patient is a safety risk to him/herself or others;
  • Clinically significant abnormality within 2 years of Screening that in the Investigator's opinion may place the patient at risk or interfere with study outcome variables;
  • Has a QT interval corrected for heart rate using Fridericia formula \> 450 msec in males or \> 470 msec in females, or evidence of clinically significant bundle branch blocks on ECG at Screening.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Clinical Site 2

Los Alamitos, California, 90720, United States

Location

Clinical Site 3

Atlanta, Georgia, 30331, United States

Location

Clinical Site 4

Decatur, Georgia, 30030, United States

Location

Clinical Site 1

Marlton, New Jersey, 08053, United States

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

lumateperone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This study includes 3 sequential study parts (Parts A, B and C). Part A consists of 4 cohorts (Cohorts 1 to 4), Part B of up to 3 cohorts (Cohorts 5 to 7), and Part C of up to 2 cohorts (Cohorts 8 and 9). Within each study part, cohorts may be enrolled in parallel.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2024

First Posted

October 4, 2024

Study Start

August 23, 2024

Primary Completion

November 20, 2025

Study Completion

November 20, 2025

Last Updated

March 12, 2026

Record last verified: 2026-03

Locations

US(4)